Nicotine Pouches in Finland No Longer Classified as Medicinal Products
24th Apr 2023
The Finnish Medicines Agency, Fimea, has recently re-evaluated its classification of nicotine pouches, determining that they are no longer considered medicinal products unless marketed explicitly for medicinal purposes or proven to be typically used as such.
This new classification departs from Fimea’s previous approach, which categorized nicotine pouches as medicinal products based on their pharmacological effects on humans due to the nicotine content. Previously, Fimea’s guidelines stipulated that nicotine pouches containing more than 4 mg of nicotine per pouch were treated as prescription drugs and could not be imported without a prescription.
As of April 4th, the Finnish customs began implementing Fimea’s new assessment in both import control and preliminary investigations. This means customs will no longer detain or seize nicotine pouches imported to Finland from that date.
Applicability of Tobacco Act and Chemicals Legislation
Despite the reclassification, nicotine pouches still meet the definition of a tobacco substitute, as referenced in the Finnish Tobacco Act, due to corresponding to tobacco products in terms of intended use but do not contain tobacco. Consequently, provisions on tobacco substitutes under the Tobacco Act will apply to these products where applicable. Additionally, chemical legislation will also apply to nicotine pouches.
The changes regarding the import of nicotine pouches do not affect import regulations on snus.
Public Consultation on Amendment of Tobacco Act
On April 20th, the Finnish government initiated a public consultation on a proposed amendment to the Tobacco Act. The proposal suggests adding a definition for smokeless nicotine products, including nicotine pouches and similar products. The amendment would prohibit the sale, distribution, or other transfers of smokeless nicotine products and, subject to certain restrictions, the import of such products.
The draft proposal is an official view of officials of the Ministry of Social Affairs and Health, and it is based on the proposals made by the working group on developing tobacco and nicotine policy. The intention is for the Act to enter into force as soon as possible.